SWISSspine: the case of a governmentally required HTA-registry for total disc arthroplasty: results of cervical disc prostheses

Abstract

Study design: Prospective multicenter observational case-series.

Objective: The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of these Medtech innovations.

Summary of background data: The Swiss federal office of public health required a mandatory nationwide HTA-registry for cervical total disc arthroplasty (TDA), among other technologies, to decide about reimbursement of these interventions.

Methods: Between March 2005 and June 2008, 808 interventions with implantation of 925 discs from 5 different suppliers were performed. Surgeon-administered outcome instruments were primary intervention, implant, and follow-up forms; patient self-reported measures were EQ-5D, COSS, and a comorbidity questionnaire. Data are recorded perioperative, at 3 months and 1 year postoperative, and annually thereafter. RESULTS. There was significant and clinically relevant reduction of neck (preoperative/postoperative 59.3/24.8 points) and arm pain (preoperative/postoperative 64.9/17.6) on visual analogue scale (VAS) and consequently decreased analgesics consumption. Similarly, quality of life (QoL) improved from preoperative 0.42 to postoperative 0.82 points on EQ-5D scale. There were 4 intraoperative complications and 23 revisions during the same hospitalization for 691 monosegmental TDAs, and 2 complications and 6 revisions for 117 2-level surgeries. A pharmacologically treated depression was identified as important risk factor for achieving a clinically relevant pain alleviation >20 points on VAS. Two-level surgery resulted in similar outcomes compared with the monosegmental interventions.

Conclusion: Cervical TDA appeared as safe and efficacious in short-term pain alleviation, consequent reduction of pain killer consumption, and in improvement of QoL. A clinically relevant pain reduction of ≥20 points was most probable if patients had preoperative pain levels ≥40 points on VAS. A pharmacologically treated depression and 2-level surgery were identified as risk factors for less pronounced pain alleviation or QoL improvement.